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Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

NCT01282827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-01-15

No results posted yet for this study

Summary

Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions with the defective visual field sectors of the visual field (primary outcome measure).

Conditions

  • Visual Impairment

Interventions

DEVICE

rtACS (verum condition)

Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000 microA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.

DEVICE

placebo stimulation

a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).

Sponsors & Collaborators

  • EBS Technologies GmbH

    collaborator INDUSTRY

  • University of Magdeburg

    lead OTHER

Principal Investigators

  • Bernhard A Sabel, Prof. Dr. · University of Magdeburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01282827 on ClinicalTrials.gov